Welcome!

Microsoft Cloud Authors: Andreas Grabner, Stackify Blog, Liz McMillan, David H Deans, Automic Blog

News Feed Item

Publication of two pivotal Phase III studies of regorafenib: Positive Phase III Data on Bayer's Regorafenib in Metastatic Colorectal Cancer (mCRC) and Gastrointestinal Stromal Tumor (GIST) Published in The Lancet

  • First publication of the global Phase III CORRECT and GRID study data of the oral multi-kinase inhibitor regorafenib

TORONTO, Nov. 27, 2012 /CNW/ - Bayer HealthCare today announced that the results of two pivotal Phase III studies for regorafenib were published online in the journal The Lancet ahead of a future print publication. Data from the CORRECT (Metastatic Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) and GRID (GIST - Regorafenib In Progressive Disease) trials provide robust evidence for the efficacy of regorafenib in patients with metastatic colorectal cancer (mCRC) or gastrointestinal stromal tumor (GIST) who have exhausted all other treatment options.

"The publication of the CORRECT and GRID trials in The Lancet signifies the potential of regorafenib as a new and effective treatment option for both mCRC and GIST, where there is a high unmet need," said Dr. Shurjeel Choudhri, Vice President, Medical and Scientific Affairs. "Bayer is dedicated to developing innovative therapies to improve patient's lives and we will continue to expand our oncology portfolio to make a difference for patients and physicians."

CORRECT Trial

In the Phase III CORRECT trial regorafenib plus best supportive care (BSC) significantly improved overall survival (OS) (HR=0.77, 1-sided p-value=0.0052) and progression-free survival (PFS) (HR=0.49, 1-sided p-value <0.000001) compared to placebo plus BSC in patients with mCRC whose disease had progressed after approved standard therapies. In the study, median OS was 6.4 months with regorafenib versus 5.0 months with placebo; median PFS was 1.9 months with regorafenib versus 1.7 months with placebo. The data also showed a survival benefit in the regorafenib arm across nearly all subgroups analyzed, including no significant difference between patients with KRAS wild-type tumor and those with KRAS mutant tumor.  No difference in overall response rate was observed.

"Although there has been progress in the treatment of metastatic colorectal cancer, drug resistance remains a huge challenge," says Dr. Christine Cripps, Professor of Medicine University of Ottawa Cancer Centre.  "Regorafenib is a unique oral multi-kinase inhibitor that has the potential to become a new standard of care in mCRC and provides hope for those patients who until now would have had no further options."

The most common grade 3+ adverse events (≥5% of patients) were hand-foot skin reaction (16.6% vs. 0.4%), fatigue (15.0% vs. 8.3%), diarrhea (8.2% vs. 2.0%), hypertension (7.6% vs. 0.8%), and rash/desquamation (5.8% vs 0.4%). Quality of life was not adversely affected by regorafenib. The most serious adverse drug reactions in patients receiving regorafenib were severe liver injury, hemorrhage and gastrointestinal perforation.

GRID Trial

The Phase III GRID trial, also published in The Lancet, showed that regorafenib plus BSC significantly improved PFS compared to placebo plus BSC (HR=0.27, p<0.000001) in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib, which means a 73% reduction in the risk of progression or death. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm. In addition, there was a positive trend in the regorafenib group in improving OS (HR=0.772, p=0.199); however, the OS did not reach statistical significance which was expected due to the cross-over design of the trial that allowed patients receiving placebo to receive regorafenib following disease progression.

Furthermore, a significantly greater disease control rate (DCR) was observed with regorafenib plus BSC compared to placebo plus BSC (52.6% vs. 9.1%; p<0.000001), DCR was defined as rate of complete response [CR] plus partial response [PR] plus durable stable disease [SD] maintained for at least 12 weeks. In addition, regorafenib demonstrated therapeutic benefit independent of prior treatment options based on analysis in pre specified subgroups that showed regorafenib had a statistically significant PFS benefit over placebo for patients receiving regorafenib as a third- or fourth-line treatment.

The most common grade 3 regorafenib-related adverse events which had higher incidence (≥5% ) in the regorafenib plus BSC vs placebo plus BSC were hypertension (27.3% vs 4.5%), hand-foot skin reaction (20.5% vs 0%), and diarrhea (7.6% vs 0%%).  Grade 4 AEs were reported at a similar incidence in the regorafenib plus BSC vs placebo plus BSC (6.8% vs 6.1%).

About the CORRECT Trial

The Phase III study CORRECT randomized 760 patients with mCRC whose disease had progressed after currently approved standard therapies to receive regorafenib plus BSC or placebo plus BSC at a 2:1 ratio. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC. The primary endpoint of this trial was OS. Secondary endpoints included PFS, objective tumor response rate and disease control rate. The safety and tolerability of the two treatment groups were also compared.

About the GRID Trial

GRID was a randomized, double-blind, placebo-controlled, multi-center, cross-over Phase III study of regorafenib for the treatment of GIST. It randomized 199 patients whose disease had progressed despite prior treatment with imatinib and sunitinib. Patients were randomized in a 2:1 ratio to receive either regorafenib (160 mg once daily, 3 weeks on/1 week off) plus BSC or placebo plus BSC to evaluate efficacy and safety. The primary endpoint of this trial was PFS, and secondary endpoints included OS, time to progression, disease control rate, tumor response rate, duration of response, and safety of regorafenib.  Patients initially randomized to placebo were allowed to cross over to open-label regorafenib once the disease progressed, of which 85% of the patients from the placebo arm did cross over.

About Stivarga® (regorafenib)

Regorafenib is an oral multi-kinase inhibitor that inhibits various kinases that are involved in mechanisms associated with tumor growth and progression (oncogenesis),  blood vessel development (angiogenesis), and the tumor microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases (VEGFR1 and murine VEGFR2/3) that play a role in tumor neoangiogenesis (the growth of new blood vessels). It also inhibits various oncogenic and tumor microenvironment kinases including, KIT, RET, RAF-1, B-RAF, B-RAFV600E, PDGFR, and FGFR1, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression.

Regorafenib has been submitted to Health Canada for marketing approval for the treatment of metastatic CRC and GIST. Market authorization in Canada has not yet been obtained.

Regorafenib was approved by the U.S. Food and Drug Administration for the treatment of mCRC and is marketed as STIVARGA® and has received priority review for treatment in GIST.  Bayer has also submitted for marketing approval of regorafenib for the treatment of metastatic CRC in the EU in May 2012. The NDA for regorafenib for the treatment of advanced CRC filed in Japan in July 2012 was granted priority review.

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the U.S. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all future global net sales of Stivarga in oncology.

About Bayer Inc.

Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international research-based group with core businesses in health care, crop science and innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer CropScience Inc., headquartered in Calgary, Alberta operates as a separate legal entity in Canada. Together, the companies play a vital role in improving the quality of life for Canadians - producing products that fight diseases, protecting crops and animals, and developing high-performance materials for applications in numerous areas of daily life. Canadian Bayer facilities include the Toronto headquarters and offices in Montréal and Calgary.

Bayer Inc. has approximately 800 employees across Canada and had sales of $808 million CDN in 2011. Globally, the Bayer Group had sales of over 36 billion Euro in 2011. Bayer Inc. invested approximately $13 million CDN in research and development in 2011. Worldwide, the Bayer Group spent the equivalent of over 2.9 billion Euro in 2011 in R&D. For more information, go to www.bayer.ca.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.


SOURCE Bayer Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
"When we talk about cloud without compromise what we're talking about is that when people think about 'I need the flexibility of the cloud' - it's the ability to create applications and run them in a cloud environment that's far more flexible,” explained Matthew Finnie, CTO of Interoute, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend 21st Cloud Expo October 31 - November 2, 2017, at the Santa Clara Convention Center, CA, and June 12-14, 2018, at the Javits Center in New York City, NY, and learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
No hype cycles or predictions of zillions of things here. IoT is big. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, Associate Partner at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He discussed the evaluation of communication standards and IoT messaging protocols, data analytics considerations, edge-to-cloud tec...
When growing capacity and power in the data center, the architectural trade-offs between server scale-up vs. scale-out continue to be debated. Both approaches are valid: scale-out adds multiple, smaller servers running in a distributed computing model, while scale-up adds fewer, more powerful servers that are capable of running larger workloads. It’s worth noting that there are additional, unique advantages that scale-up architectures offer. One big advantage is large memory and compute capacity...
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists examined how DevOps helps to meet the de...
Amazon started as an online bookseller 20 years ago. Since then, it has evolved into a technology juggernaut that has disrupted multiple markets and industries and touches many aspects of our lives. It is a relentless technology and business model innovator driving disruption throughout numerous ecosystems. Amazon’s AWS revenues alone are approaching $16B a year making it one of the largest IT companies in the world. With dominant offerings in Cloud, IoT, eCommerce, Big Data, AI, Digital Assista...
Artificial intelligence, machine learning, neural networks. We’re in the midst of a wave of excitement around AI such as hasn’t been seen for a few decades. But those previous periods of inflated expectations led to troughs of disappointment. Will this time be different? Most likely. Applications of AI such as predictive analytics are already decreasing costs and improving reliability of industrial machinery. Furthermore, the funding and research going into AI now comes from a wide range of com...
Internet of @ThingsExpo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 21st Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devic...
We build IoT infrastructure products - when you have to integrate different devices, different systems and cloud you have to build an application to do that but we eliminate the need to build an application. Our products can integrate any device, any system, any cloud regardless of protocol," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA
SYS-CON Events announced today that Ayehu will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on October 31 - November 2, 2017 at the Santa Clara Convention Center in Santa Clara California. Ayehu provides IT Process Automation & Orchestration solutions for IT and Security professionals to identify and resolve critical incidents and enable rapid containment, eradication, and recovery from cyber security breaches. Ayehu provides customers greater control over IT infras...
SYS-CON Events announced today that MobiDev, a client-oriented software development company, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex software systems for startups and enterprises. Since 2009 it has grown from a small group of passionate engineers and business...
SYS-CON Events announced today that GrapeUp, the leading provider of rapid product development at the speed of business, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company, specialized in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market acr...
SYS-CON Events announced today that Enzu will exhibit at SYS-CON's 21st Int\ernational Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive advantage. By offering a suite of proven hosting and management services, Enzu wants companies to focus on the core of their ...
SYS-CON Events announced today that Cloud Academy named "Bronze Sponsor" of 21st International Cloud Expo which will take place October 31 - November 2, 2017 at the Santa Clara Convention Center in Santa Clara, CA. Cloud Academy is the industry’s most innovative, vendor-neutral cloud technology training platform. Cloud Academy provides continuous learning solutions for individuals and enterprise teams for Amazon Web Services, Microsoft Azure, Google Cloud Platform, and the most popular cloud com...
SYS-CON Events announced today that IBM has been named “Diamond Sponsor” of SYS-CON's 21st Cloud Expo, which will take place on October 31 through November 2nd 2017 at the Santa Clara Convention Center in Santa Clara, California.
In his session at Cloud Expo, Alan Winters, an entertainment executive/TV producer turned serial entrepreneur, presented a success story of an entrepreneur who has both suffered through and benefited from offshore development across multiple businesses: The smart choice, or how to select the right offshore development partner Warning signs, or how to minimize chances of making the wrong choice Collaboration, or how to establish the most effective work processes Budget control, or how to ma...
SYS-CON Events announced today that CA Technologies has been named "Platinum Sponsor" of SYS-CON's 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business - from apparel to energy - is being rewritten by software. From planning to development to management to security, CA creates software that fuels transformation for companies in the applic...
Multiple data types are pouring into IoT deployments. Data is coming in small packages as well as enormous files and data streams of many sizes. Widespread use of mobile devices adds to the total. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists looked at the tools and environments that are being put to use in IoT deployments, as well as the team skills a modern enterprise IT shop needs to keep things running, get a handle on all this data, and deliver...
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), provided an overview of various initiatives to certify the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldwide re...
IoT solutions exploit operational data generated by Internet-connected smart “things” for the purpose of gaining operational insight and producing “better outcomes” (for example, create new business models, eliminate unscheduled maintenance, etc.). The explosive proliferation of IoT solutions will result in an exponential growth in the volume of IoT data, precipitating significant Information Governance issues: who owns the IoT data, what are the rights/duties of IoT solutions adopters towards t...